Brand
Advanced Accelerator Applications USA, Inc.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Advanced Accelerator Applications USA, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-10-09FDA-DrugClass IIPluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61
CGMP deviations
- 2023-08-23FDA-DrugClass IIIPLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61
Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date
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